About this trial
Correct use of daily medications containing inhaled corticosteroids is key for asthma control, yet children with intellectual and developmental disabilities (IDD) face additional barriers to proper inhaler use. Smart inhalers, a novel technology that provides guidance and immediate feedback on inhaler use techniques, have been shown to enhance correct medication administration in the typically developing pediatric population, but their effectiveness has not been evaluated on the pediatric IDD population. This study aims to investigate whether daily application of smart inhalers (1) is feasible and acceptable in the IDD population, (2) improves the rate of correct medication administration, and (3) results in improvement in lung function. This effort aims to promote better asthma management in the IDD population.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adolescents ages 10-17 years
Diagnosis of mild-to-moderate intellectual disability: ICD-10: F70-F71 and/or diagnosis of developmental disability, including autism: ICD-10: F80-89
Diagnosis of moderate-to-severe asthma or moderate or severe unspecified asthma: ICD-10: J45.40-J45.909
Parent/legal guardian is willing to answer questions about their child.
Disqualifiers
Health status or any clinical conditions: Limited life expectancy, co-existing disease or other characteristics that precludes appropriate diagnosis, treatment, or follow-up in the trial.
Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
Trial design
Parallel
Treatments tested in this trial
Use of smart inhaler to enhance asthma inhaler proficiency
BehavioralThe application of the smart inhaler technology to enhance asthma inhaler proficiency
Treatment groups
Trial outcomes
Primary outcomes
Feasibility of smart inhaler device
Feasibility will be determined by data completeness: Ratio of days on which there are valid smart inhaler data out of the total number of days
Acceptability of smart inhaler
Acceptability will be measured by response rate on user satisfaction survey.
Usability of smart inhaler
Usability will be measured by ease of use smart inhaler survey.
Sponsors and contacts
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